Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).
Phase I: Initial doses will be:
Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and Herceptin (4) 2 mg/kg weekly.
Sample size will depend on the number of patients recruited during dose escalation. Three patients must be recruited in each dose level. If one out of three experiences a dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level. Considering that there are 4 dose levels to be tested, the estimated number of patients is 9 to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the study.
Phase II: The average pathological complete response rate reported in other trials is around 11%. The investigators expect to achieve an increase of 14% on this rate; that is, they expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially needed. If at least 3 pathological complete responses are achieved, recruitment will continue to up to 53 patients. At least 10 pathological complete responses are needed to probe the hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must be recruited for the trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Phase I-II Clinical Trial to Evaluate Treatment With Myocet/Taxotere/Herceptin as Primary Chemotherapy Treatment for HER2neu Positive Breast Cancer Patients|
- Efficacy and tolerability of Myocet/Taxotere/Herceptin
- Tumour response (clinical and radiological response)
- Surgery (conservative surgery versus mastectomy)
- Potential cardiac toxicity (left ventricular ejection fraction [LVEF] by multiple-gated acquisition [MUGA])
- Overall tolerability
- Post-surgery node status
- Disease-free survival
- Molecular changes in blood and tissue exams
|Study Start Date:||January 2004|
|Study Completion Date:||December 2007|
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Antonio Antón, MD., PhD.||Spanish Breast Cancer Research Group (GEICAM)|